Are probiotics supplements regulated?
This unrelenting question is one of the biggest misconceptions that people around the world have about these products. The simple answer? Yes, they are regulated, but understanding the regulations and how they are applied in different markets is critical to finding success.
In the EU, probiotic foods mainly fermented milks and supplements fall within the scope of General Food Law. The Communication on the nutritional and health effects of probiotics is regulated by the Nutrition & Health Claims Regulation 1924/2006 (NHCR).
Food business operators have to obtain a prior-approval authorization from the EU Commission to be entitled to communicate on the beneficial effects of their products on the product label or in advertising (i.e., health claim approval). NHCR applies to nutrition claims such as “low fat” or “high fibre” and to health claims. Outside of the EU, claims and associated-regulatory implications are possible and highly depend on the intended use. This dictates whether a pre-marketing approval or a notification from authorities is needed.
In the United States, FDA has direct supervision over the probiotic industry and regulates all dietary supplements under the Dietary Supplement Health and Education Act of 1994 (DSHEA). This regulation involves many levels of FDA involvement including document reviews, audits and more. Within the U.S. market, there are further misconceptions around the requirements for efficacy and quality of dietary supplements.
Consult 21 CFR (Code of Federal Regulations) §111 and §117 where the sections cover hazard and quality analysis when producing dietary supplements specifically ensuring that product specifications are created and followed using adequate quality systems that warrant consistency and traceability of production. The efficacy requirement is also legislated by DSHEA, and each firm selling the product must ensure that they have the necessary evidence to support whatever claims they are purporting on the label.
Misbranded and adulterated products not only have the FDA to contend with, but additional regulatory action may be brought against the “bad players” from the Federal Trade Commission (FTC). Both FDA and FTC have made major strides to curb products that may be unfit for sale or are making claims that are out of scope and have taken action to be able to remove these from the market.
In the United States and Australia, structure function claims are permitted without pre-approval provided they are truthful, not misleading, and substantiated by competent and reliable evidence. Regulators conduct a strict post-marketing surveillance of such claims.
Other areas such as Canada, Brazil, Korea, and Switzerland allow specific claims after review and approval from health authorities. In certain countries, general claims for probiotics are also permitted upon review such as Canada, Brazil, China, and South Africa. Even some countries in the EU such as Italy, Czechia, the Netherlands, Denmark, and recently Spain, tolerate label claims such as “contains probiotics” without pre-approval.
Regulations are part of the probiotic industry’s existence. Regulations for probiotics across the world are as varied as the cultures of the countries they serve. A must for any organization with global reach for commercialized probiotics products is a very robust regulatory affairs department in order to help navigate the different mazes.
In early 2021, the International Probiotics Association (IPA) published the IPA Regulatory Book. This project grew directly out of IPA’s mission of promoting the safe and efficacious use of probiotics throughout the world. This includes supporting IPA members that are probiotic companies in good standing with science-based products that adhere to all regulatory guidelines and requirements.
The IPA Regulatory Book is a reference guide and a tool that allows IPA members quick access to regulatory questions regarding the commercialization of their probiotic products. The book currently has a 28-country reference. An additional 12 countries will be added to the reference in 2022. This book is and will continue to be dynamic as it will be reviewed annually with additional countries and regulatory updates.
NOTE: To learn more about IPA membership and benefits including access to the IPA Regulatory Book, contact the organization at [email protected]